Hi Dogo, I posted some comments on SA today.
If an article is clearly constructed with the purpose of creating a negative image it is difficult to decide where to start. Just take the title: it suggests imetelstat is haunted by a series of death incidents. But reading the article you will see that there is virtualy nothing concrete that justifies the suggestion that deaths are connected with the use of imetelstat. It is no surprise there are deaths in IMbark, because these patients are terminally ill and have very weak health conditions. We already knew that not all patients respond to imetelstat, so it is inevitable that patients die during the trial.
Then we have the heavily constructed and twisted 'opinion' of Mayo Clinic regarding toxicity. Dr.Tefferi, who was principle investigator on this Mayo Pilot Study, in fact said something completely different about that. See below my response to the author, a repost from SA:
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Quote from the SA article:
'In addition, we want to point out that the Pilot Study's enrollment was discontinued early, which suggests to us that the trial wasn't promising in later results and/or that the Mayo Clinic may have found the safety profile of imetelstat unacceptable.'
EVERY trial will discontinue at a certain point, no matter how successful a drug is. Do you think a single healthcare center can enroll an endless number of patients?
You ignore the most important fact: that the trial is still going on, which suggests that patients are still benefiting and that the safety profile is acceptable and manageable. If you would taken the effort of looking at the CT site you would have known that.
Have you spoken with the Mayo Clinic? Can you provide any evidence of your assumption? Dr. Tefferi has a very different opinion from what you say:
'We have not seen any grade 3 or 4 toxicity at all. We were very happy with that'
https://www.youtube.com/watch?v=sBVRfTM2EnI
Your reasoning is against all logic and against the facts. If the Mayo data would have proven that imet has an 'unacceptable' safety profile (as you suggest), why then:
1) is the FDA allowing the trials to go on while keeping patients exposed to this drug
2) why would JnJ have entered into the license agreement in the first place
3) why would the FDA have granted FTD
4) why would Dr. Raza say that imetelstat side effects are manageable and even less severe then in well known and approved drugs like lenalidome and HMA's?
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When we will have some positive news - hopefully soon - that article will be quickly forgotten.